FDA Inspection
Evergreen Orthopedic Research Lab, LLCEvergreen Orthopedic Research Lab, LLC – FDA Inspection, Oct 29, 2015
Record Details
This FDA Inspection record concerns Evergreen Orthopedic Research Lab, LLC, with an inspection on October 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 29, 2015
- Product Type
- Devices
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ID · fa031fe5-a19d-4a63-8af8-1f681c810d62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945848
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Evergreen Orthopedic Research Lab, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Evergreen Orthopedic Research Lab, LLC
- FDA Inspection 1086103 - 2019-04-12
- FDA Inspection 852501 - 2013-11-01
- FDA Inspection 723717 - 2011-05-05
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